Preventing blood clots in cancer patients with central venous catheters
Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters: a Randomized Controlled Trial
This study is testing if a daily dose of a blood thinner called rivaroxaban can help prevent blood clots in cancer patients who have just had a central venous catheter placed.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1828 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Locations | 11 sites (Halifax, Nova Scotia and 10 other locations) |
| Trial ID | NCT05029063 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness and safety of rivaroxaban, a blood thinner, in preventing venous thromboembolism (VTE) in patients with active cancer who have central venous catheters (CVC) inserted within the last 72 hours. It is a double-blind, randomized controlled trial comparing a daily dose of 10mg rivaroxaban to a placebo. The study will be conducted across nine centers in Canada, focusing on a population at high risk for blood clots due to their cancer and CVC. Participants will be monitored for VTE occurrences and any adverse effects related to the medication.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a new or existing cancer diagnosis and a central venous catheter placed within the last 72 hours.
Not a fit: Patients who have had their central venous catheter in place for more than 72 hours or those requiring anticoagulation for other medical reasons may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of blood clots in cancer patients with central venous catheters, improving their overall treatment outcomes.
How similar studies have performed: Other studies have shown promising results with anticoagulant prophylaxis in similar patient populations, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Patients 18 years of age or older with a new or existing diagnosis of cancer and a CVC inserted in the last 72 hours.
Exclusion criteria:
1. CVC in place for \>72 hours
2. Patient requires anticoagulation for other indications
3. Concomitant use of dual antiplatelet therapy
4. Major bleeding event in the last 4 weeks
5. Patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp (such as cobicistat, ketoconazole, itraconazole, posaconazole, or ritonavir).
6. Known pregnancy or plan to become pregnant in next 3 months
7. Severe renal insufficiency (Creatinine clearance \<30 mL/min (defined by Cockcroft-Gault) in the previous 3 months
8. Documented severe liver disease (e.g., acute clinical hepatitis, chronic active hepatitis or cirrhosis) in the previous 3 months
9. Known thrombocytopenia (platelet count \< 50x 109/L) in the previous 3 months
10. Known allergy to rivaroxaban
11. Life expectancy \<3 months
12. History of condition at increased bleeding risk including, but not limited to:
1. cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, spontaneous or acquired impairment of hemostasis in the past 4 weeks.
2. Chronic hemorrhagic disorder
13. Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin only
14. Refused or unable to obtain consent
Where this trial is running
Halifax, Nova Scotia and 10 other locations
- Nova Scotia Health — Halifax, Nova Scotia, Canada (Recruiting)
- William Osler Health System — Brampton, Ontario, Canada (Recruiting)
- HHS - Juravinski Hospital — Hamilton, Ontario, Canada (Recruiting)
- Ottawa Hospital Research Institute- The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
- Sault Area Hospital — Sault Ste. Marie, Ontario, Canada (Recruiting)
- Niagara Health — St. Catharines, Ontario, Canada (Recruiting)
- Windsor Regional Hospital — Windsor, Ontario, Canada (Recruiting)
- CISSS Montérégie-Centre HOPITAL CHARLES LEMOYNE — Greenfield Park, Quebec, Canada (Recruiting)
- Centre Intégré de santé et de services sociaux de Chaudière-Appalaches — Lévis, Quebec, Canada (Recruiting)
- Jewish General Hospital — Montreal, Quebec, Canada (Recruiting)
- McGill University Health Center — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Dr. Marc Carrier — Ottawa Hospital Research Institute
- Study coordinator: Bashour Yazji
- Email: byazji@ohri.ca
- Phone: 613-737-8899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.